About
As of 2026, Scientific and Medical Affairs Consulting, LLC (SMAC) continues to provide exceptional scientific expertise to support drug development from pre-IND (Investigational New Drug) through commercialization. With a wealth of experience, SMAC has been a trusted partner for over 35 biotechnology and pharmaceutical companies, assisting them in navigating the challenges and dynamic landscape of various therapeutic areas.
SMAC's dedicated and diverse team possesses a range of complementary skill sets, allowing them to effectively address each client's unique challenges with precision and efficiency. By leveraging our in-depth knowledge and understanding of the industry, SMAC offers tailored solutions to support our clients' drug development efforts.
From early-stage research to regulatory submissions and commercialization strategies, SMAC collaborates closely with their clients to provide comprehensive scientific and medical affairs support.
By partnering with SMAC, biotechnology and pharmaceutical companies gain access to a team of seasoned professionals who are well-versed in the latest scientific advancements and regulatory requirements. With a focus on optimum speed, quality, and expertise, SMAC strives to accelerate the development of innovative therapies and contribute to the improvement of patient outcomes.
Our Team
Judith Steenbergen, PhD
CEO and Founder
20+ years of senior MA and Clinical Development leadership. Led multiple IND/NDA/MAA filings, FDA advisory boards, and CLSI/EUCAST breakpoint negotiations.
Hina Patel, PharmD, BCPS
Executive Vice President
15+ years in pharmaceutical MA, including field-based MSL and leadership roles, MA buildout, product strategy, business development, government affairs, and global expansion.
Amira Bhalodi, PharmD
Senior Consultant
Clinical pharmacist with expertise in anti-infective scientific strategy, publication planning, and healthcare stakeholder engagement.
Evan Tzanis
Senior Advisor
With over 30 years of experience in the pharmaceutical industry, Evan has played a key role in securing regulatory approval for ten products across a broad range of therapeutic areas. His work has spanned treatments for infectious diseases, dermatological conditions, and central nervous system disorders.
Rolf Wagenaar
Senior Director
30 years in commercial leadership. Successfully led launch and commercial efforts for 8 anti-infective products. Moderated 75+ advisory boards.
Shelley Campeau, PhD, D(ABMM)
Senior Consultant
Board-certified clinical microbiologist with expertise in AST development, in vitro diagnostic FDA-regulated studies, and breakpoint submissions.
Esther Long
Business Manager
Manages contracts and agreements and oversees the operational and financial coordination of projects and partnerships within our organization.
Gabriella Cohen
Research Assistant
Current PharmD candidate at the UNC Eshelman School of Pharmacy, bringing four years of experience in the infectious disease space, with a focus on emerging public health challenges and evidence-based research.
Elizabeth Alexander
Consultant
Elizabeth is a board-certified infectious disease physician with over 12 years of industry experience in clinical development. She has a demonstrated record of success, resulting in regulatory approval and launch of 5 therapeutic agents (Sotrovimab, Lefamulin, Meropenem-Vaborbactam, Minocycline (EU) and Oritavancin) to date and has worked across both small molecules and biologics with deep experience in multiple regulatory submissions including: IND, NDA, BLA, MAA, EUA and global regulatory submissions.